Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00943397 | Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232) | PHASE3 | COMPLETED | 190 | — | — | Apr 1, 2001 | Nov 1, 2001 | Feb 3, 2022 | - | — |
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Montelukast |
| 2 | ACTIVE_COMPARATOR | Usual Care |
| Name | Type | Description |
|---|---|---|
| montelukast sodium | DRUG | Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks |
| Comparator: Usual Care | DRUG | Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks |
Inclusion Criteria: * Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683) OR: * Patient is in good, stable health * Patient has been fed solid foods for at least 1 month * Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of ag...